Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLYCOPYRRONIUM BROMIDE; MOMETASONE FUROATE; INDACATEROL ACETATE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
GLYCOPYRRONIUM BROMIDE; MOMETASONE FUROATE; INDACATEROL ACETATE
10 Capsules and 1 Inhaler Units; 30 Capsules and 1 inhaler Units
NOVARTIS PHARMA STEIN AG
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ ENERZAIR ® BREEZHALER ® INHALATION POWDER HARD CAPSULES Indacaterol Acetate, Glycopyrronium Bromide and Mometasone Furoate (150/50/160 micrograms) _________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Enerzair Breezhaler is used for 2. How Enerzair Breezhaler works 3. Before you use Enerzair Breezhaler 4. How to use Enerzair Breezhaler 5. While you are using it 6. Side effects 7. Storage and Disposal of Enerzair Breezhaler 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Instructions for use of Enerzair Breezhaler Inhaler. WHAT ENERZAIR BREEZHALER IS USED FOR Enerzair Breezhaler is used regularly as treatment for asthma in adults. Asthma is a serious, long-term lung disease where the muscles around the smaller airways become tight (bronchoconstriction) and inflamed. Symptoms come and go and include shortness of breath, wheezing, chest tightness and cough. You should use Enerzair Breezhaler every day and not only when you have breathing problems or other symptoms of asthma. This will ensure that it controls your asthma properly. Do not use this medicine to relieve a sudden attack of breathlessness or wheezing. If you have any questions about how Enerzair Breezhaler works or why this medicine has been prescribed for you, ask your doctor. HOW ENERZAIR BREEZHALER WORKS Enerzair Breezhaler contains three active substances: • indacaterol • glycopyrronium • mometasone furoate Indacaterol and glycopyrronium belong to a group of medicines called bronchodilators. They work in different ways to relax the muscles of the small airways in the lungs. This helps to open the airways and makes it easier for air to get in and out of the lungs. When they are taken regularly, they help the small airways to remain open. Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids). Corticosteroids reduce the swelling and irritation ( Прочитать полный документ
Novartis Page 2 Malaysia Package Leaflet 05-Mar-2020 Corr.10-Jun-2020 Enerzair Breezhaler 1. NAME OF THE MEDICINAL PRODUCT Enerzair Breezhaler 150 micrograms/50 micrograms/160 micrograms inhalation powder, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150 mcg of indacaterol (as acetate), 63 mcg of glycopyrronium bromide equivalent to 50 mcg of glycopyrronium and 160 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 114 mcg of indacaterol (as acetate), 58 mcg of glycopyrronium bromide equivalent to 46 mcg of glycopyrronium and 136 mcg of mometasone furoate. Excipient(s) with known effect Each capsule contains 25 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule (inhalation powder). Capsules with green transparent cap and uncoloured transparent body containing a white powder, with the product code “IGM150-50-160” printed in black above two black bars on the body and with the product logo printed in black and surrounded by a black bar on the cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Enerzair Breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta 2 -agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one capsule to be inhaled once daily. The maximum recommended dose is 114 mcg/46 mcg/136 mcg once daily. Treatment should be administered at the same time of the day each day. It can be administered irrespective of the time of the day. If a dose is missed, it should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day. _Special populations _ _Elderly population _ No dose adjustment is required in elderly patients (65 years of age or older) Прочитать полный документ